Fabrizi Fabrizio, Lunghi Giovanna, Aucella Filippo, Mangano Stefano, Barbisoni Francesco, Bisegna Sergio, Vigilante Domenico, Limido Aurelio, Martin Paul
Division of Nephrology, Maggiore Hospital, IRCCS, via Commenda 15, 20122 Milan, Italy.
J Clin Microbiol. 2005 Jan;43(1):414-20. doi: 10.1128/JCM.43.1.414-420.2005.
Dialysis patients remain a high-risk group for hepatitis C virus (HCV) infection. The current diagnosis of HCV infection among dialysis patients includes serological assays and nucleic acid amplification technology (NAT) for assessing serum anti-HCV antibody and HCV viremia, respectively. However, current NAT techniques are expensive and labor-intensive and often lack standardization. An assay prototype designed to detect and quantify total HCV core antigen (total HCV core Ag) protein in serum and plasma in the presence or absence of anti-HCV antibodies has been recently developed. A comparison between a total anti-HCV core Ag enzyme-linked immunosorbent assay (ELISA) and a quantitative HCV RNA assay based on reverse transcription-PCR (RT-PCR) (Amplicor HCV Monitor test) was performed using a large (n = 305) cohort of ELISA HCV 3.0 HCV-negative and -positive patients on maintenance dialysis. The concentrations of HCV core Ag and HCV RNA levels (measured by RT-PCR) were significantly correlated (r = 0.471, P = 0.0001) over a wide range of HCV RNA levels and were maintained among different HCV genotypes (HCV genotype 1, r = 0.862, P = 0.0001; HCV genotype 2, r = 0.691, P = 0.0001). We estimated that 1 pg of total HCV core Ag per ml is equivalent to approximately 19.952 IU of HCV RNA per ml, even if the wide range in the ratio of core Ag to HCV RNA (95% confidence intervals, 2.8 x 10(3) to 1.6 x 10(5) IU/ml) precluded definitive conclusions. In summary, total HCV core Ag proved to be useful for performing HCV RNA measurement among dialysis patients in routine laboratories without the need for special equipment or training. The present study supports the use of the total anti-HCV core Ag ELISA for assessing viral load among dialysis patients with HCV infection.
透析患者仍然是丙型肝炎病毒（HCV）感染的高危人群。目前透析患者中HCV感染的诊断方法包括血清学检测和核酸扩增技术（NAT），分别用于评估血清抗-HCV抗体和HCV病毒血症。然而，目前的NAT技术昂贵且 labor-intensive，并且常常缺乏标准化。最近开发了一种检测原型，用于在有或没有抗-HCV抗体的情况下检测和定量血清和血浆中的总HCV核心抗原（总HCV核心Ag）蛋白。使用一大群（n = 305）维持性透析的ELISA HCV 3.0 HCV阴性和阳性患者，对总抗-HCV核心Ag酶联免疫吸附测定（ELISA）和基于逆转录-PCR（RT-PCR）的定量HCV RNA测定（Amplicor HCV Monitor检测）进行了比较。在广泛的HCV RNA水平范围内，HCV核心Ag浓度和HCV RNA水平（通过RT-PCR测量）显著相关（r = 0.471，P = 0.0001），并且在不同的HCV基因型中保持一致（HCV基因型1，r = 0.862，P = 0.0001；HCV基因型2，r = 0.691，P = 0.0001）。我们估计每毫升1 pg的总HCV核心Ag约相当于每毫升19.952 IU的HCV RNA，即使核心Ag与HCV RNA的比例范围很宽（95%置信区间，2.8×10³至1.6×10⁵ IU/ml），也无法得出明确结论。总之，总HCV核心Ag被证明可用于常规实验室中透析患者的HCV RNA测量，而无需特殊设备或培训。本研究支持使用总抗-HCV核心Ag ELISA评估HCV感染透析患者的病毒载量。
